India’s First USFDA-Cleared Heart-Lung Machine Set for Local Production, Reducing Import Dependence
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The startup has also secured export orders from the United States, intending to serve both domestic and international markets.
Vadodara-based Mediyant Technologies has secured regulatory approvals for the country's first locally manufactured heart-lung machine with both USFDA 510(k) clearance and a CDSCO Class C manufacturing licence.
The milestone positions the startup to begin commercial production while expanding its footprint in high-end cardiac medical devices in India.
Hiren Desai, founder of Mediyant Technologies, said the achievement reflects nearly two decades of work in the cardiac medical equipment industry.
"When we started servicing imported heart-lung machines, the objective was to understand the technology thoroughly and eventually build it in India. Today, that experience has enabled us to manufacture the machine in Vadodara," he said.
"This is not merely an imported product being assembled locally. The engineering, design and manufacturing have been carried out in India, and our aim is to increase localisation further in the coming years," Desai added.
The Indian heart-lung machine market was valued at approximately USD 73.1 Mn in 2023 and is projected to reach USD 121.4 Mn by 2030, reflecting growing demand for cardiac surgery infrastructure.
According to industry estimates, India performs between 60,000 and one lakh open-heart surgeries every year and currently has around 600 to 1,200 heart-lung machines installed across hospitals.
With cardiovascular diseases continuing to be one of the leading causes of mortality in the country, demand for advanced cardiac surgery equipment is expected to rise steadily alongside the expansion of specialised cardiac care centres.
The startup also said it has already secured export orders from the United States, signalling its intention to serve both domestic and international markets.
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